Senior/ Regulatory Specialist (quality), Therapeutic Products Branch

Singapore, Singapore

Job Description


Quality Evaluation of Therapeutic Products

  • Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval to assure the quality of medicines supplied in Singapore
  • Provide advice / guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public
  • Participate in projects and process/regulatory review
Job Requirements
  • Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, biochemistry, chemistry. pharmacy or related disciplines
  • Experienced in pharmaceutical manufacturing and quality control of biologics and/or chemcial drug products
  • Experience in the area of analytical assay development would be an advantage.
  • Knowledge of chemistry/molecular biology and manufacturing of pharmaceuticals / biologics
  • Knowledge of drug development process and drug regulations
  • Knowledge of international regulatory guidelines
  • Good communication and interpersonal skills
  • Able to work independently, as well as in a team
  • Able to work effectively with people from different backgrounds
  • Highly motivated with strong desire to protect public health and safety

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Job Detail

  • Job Id
    JD1356025
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned